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      Detection of advanced colorectal neoplasia and relative colonoscopy workloads using quantitative faecal immunochemical tests: an observational study exploring the effects of simultaneous adjustment of both sample number and test positivity threshold

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          Abstract

          Objective

          When screening for colorectal cancer (CRC) using quantitative faecal immunochemical tests (FIT), test parameters requiring consideration are the faecal haemoglobin concentration (f-Hb) positivity cut-off and the number of stools sampled. This observational study explored variation in f-Hb between samples and the relationship between sensitivity for advanced neoplasia (AN, cancer or advanced adenoma) and colonoscopy workload across a range of independently-adjusted parameter combinations.

          Design

          Quantitative FIT data (OC-Sensor) were accessed from individuals undergoing personalised colonoscopic screening with an offer of 2-sample FIT in the intervening years. We estimated variation in f-Hb between samples in 12 710 completing 2-sample FIT, plus test positivity rates (colonoscopy workload) and sensitivity for AN according to parameter combinations in 4037 instances where FIT was done in the year preceding colonoscopy.

          Results

          There was large within-subject variability between samples, with the ratio for the second to the first sample f-Hb ranging up to 18-fold for all cases, and up to 56-fold for AN cases. Sensitivity for AN was greatest at lower f-Hb cut-offs and/or using 2-sample FIT. Colonoscopy workload varied according to how parameters were combined. Using different cut-offs for 1-sample FIT and 2-sample FIT to return similar sensitivity, workload was less with 2-sample FIT when the sensitivity goal exceeded 35%.

          Conclusion

          Variation in f-Hb between samples is such that both parameters are crucial determinants of sensitivity and workload; independent adjustment of each should be considered. The 2-sample FIT approach is best for detecting advanced adenomas as well as CRC provided that the colonoscopy workload is feasible.

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          Most cited references42

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          Colorectal cancer screening: a global overview of existing programmes.

          Colorectal cancer (CRC) ranks third among the most commonly diagnosed cancers worldwide, with wide geographical variation in incidence and mortality across the world. Despite proof that screening can decrease CRC incidence and mortality, CRC screening is only offered to a small proportion of the target population worldwide. Throughout the world there are widespread differences in CRC screening implementation status and strategy. Differences can be attributed to geographical variation in CRC incidence, economic resources, healthcare structure and infrastructure to support screening such as the ability to identify the target population at risk and cancer registry availability. This review highlights issues to consider when implementing a CRC screening programme and gives a worldwide overview of CRC burden and the current status of screening programmes, with focus on international differences.
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            Effectiveness of fecal immunochemical testing in reducing colorectal cancer mortality from the One Million Taiwanese Screening Program

            BACKGROUND The effectiveness of fecal immunochemical testing (FIT) in reducing colorectal cancer (CRC) mortality has not yet been fully assessed in a large, population-based service screening program. METHODS A prospective cohort study of the follow-up of approximately 5 million Taiwanese from 2004 to 2009 was conducted to compare CRC mortality for an exposed (screened) group and an unexposed (unscreened) group in a population-based CRC screening service targeting community residents of Taiwan who were 50 to 69 years old. Given clinical capacity, this nationwide screening program was first rolled out in 2004. In all, 1,160,895 eligible subjects who were 50 to 69 years old (ie, 21.4% of the 5,417,699 subjects of the underlying population) participated in the biennial nationwide screening program by 2009. RESULTS The actual effectiveness in reducing CRC mortality attributed to the FIT screening was 62% (relative rate for the screened group vs the unscreened group, 0.38; 95% confidence interval, 0.35-0.42) with a maximum follow-up of 6 years. The 21.4% coverage of the population receiving FIT led to a significant 10% reduction in CRC mortality (relative rate, 0.90; 95% confidence interval, 0.84-0.95) after adjustments for a self-selection bias. CONCLUSIONS This large, prospective Taiwanese cohort undergoing population-based FIT screening for CRC had the statistical power to demonstrate a significant CRC mortality reduction, although the follow-up time was short. Although such findings are informative for health decision makers, continued follow-up of this large cohort will be required to estimate the long-term impact of FIT screening if the covered population is expanded. Cancer 2015;121:3221–3229. © 2015 American Cancer Society. A significant reduction in colorectal cancer mortality resulting from fecal immunochemical testing is demonstrated by a large, population-based, nationwide service screening program with a maximum follow-up of 6 years. Although long-term follow-up of this nationwide service screening program is required, these findings are useful for convincing health decision makers that the continuous promotion of such a nationwide screening program is worthwhile.
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              Real-Time Monitoring of Results During First Year of Dutch Colorectal Cancer Screening Program and Optimization by Altering Fecal Immunochemical Test Cut-Off Levels

              After careful pilot studies and planning, the national screening program for colorectal cancer (CRC), with biennial fecal immunochemical tests (FITs), was initiated in The Netherlands in 2014. A national information system for real-time monitoring was developed to allow for timely evaluation. Data were collected from the first year of this screening program to determine the importance of planning and monitoring for optimal screening program performance.
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                Author and article information

                Journal
                BMJ Open Gastroenterol
                BMJ Open Gastroenterol
                bmjgast
                bmjgast
                BMJ Open Gastroenterology
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2054-4774
                2020
                29 September 2020
                : 7
                : 1
                : e000517
                Affiliations
                [1 ]departmentCancer Research, Flinders Health and Medical Research Institute , Flinders University , Adelaide, South Australia, Australia
                [2 ]departmentBiostatistics, Flinders Prevention, Promotion and Primary Health Care, General Practice , Flinders University , Adelaide, South Australia, Australia
                [3 ]departmentFlinders Centre for Innovation in Cancer , Flinders Medical Centre , Bedford Park, South Australia, Australia
                Author notes
                [Correspondence to ] Professor Graeme P Young; graeme.young@ 123456flinders.edu.au
                Author information
                http://orcid.org/0000-0001-9458-8383
                Article
                bmjgast-2020-000517
                10.1136/bmjgast-2020-000517
                7526287
                32994195
                03959f4e-7bd5-4012-8e36-7fc584d8c963
                © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 13 August 2020
                : 27 August 2020
                : 05 September 2020
                Funding
                Funded by: Eiken Chemical Company;
                Award ID: Not relevant; donated test kits only.
                Categories
                Colorectal Cancer
                1506
                Custom metadata
                unlocked

                colorectal cancer screening,colonoscopy,gastrointestinal bleeding

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